Recall Z-1139-2012
Ion Genius, Inc. · initiated January 6, 2012
Product
IELLIOS Product Usage: Muscle stimulation
Codes / lots: all units
Reason for recall
Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
FDA-determined cause: Nonconforming Material/Component
Action taken
Ion Genius sent a Medical Device Product Recall letters to all affected customers on January 6, 2012. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to check their inventory for the affected products and return immediately to Ion Genius for replacements. Customers returning affected products should call the firm so that a shipping label can be provided. Customers were instructed to be completed the Response Form and returned to Ion Genius by fax at 808-395-0787. For questions and concerns contact Xanya Sofra-Weiss at 808-222-2664 or email x@arasysperfector.com.
Details
- Recall number
- Z-1139-2012
- Initiated
- January 6, 2012
- Posted by FDA
- March 1, 2012
- Terminated
- May 21, 2015
- Product code
- NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Quantity
- 72 cables in total, amounts of other devices not reported
- Distribution
- Worldwide Distribution - (USA) Nationwide Distribution
- Recalling firm
- Ion Genius, Inc., Honolulu, HI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1137-2012 | Perfector Product Usage: Muscle stimulationWires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations.… | 01/06/2012Terminated |
| Z-1138-2012 | Ion Magnum Product Usage: Muscle stimulationWires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations.… | 01/06/2012Terminated |
| Z-1140-2012 | iPico Product Usage: Muscle stimulationWires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations.… | 01/06/2012Terminated |
| Z-1141-2012 | Arasys Product Usage: Muscle stimulationWires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations.… | 01/06/2012Terminated |